10.17037/DATA.00005346
The VITALITY randomised controlled trial investigated the effectiveness of vitamin D and calcium supplementation on bone density in adolescents living with HIV. Nested within VITALITY, this pilot trial investigated the effectiveness of electronic monitoring devices (EMDs) on adherence to vitamin D supplementation in Harare, Zimbabwe.
169 adolescents living with HIV were randomised to receive an EMD (N=97) or no EMD (n=72) for 24 weeks. 84 of the adolescents were taking vitamin D supplements (N=50 with EMD, N=34 without EMD). The pilot trial compared 25OHD levels in blood between the EMD and non-EMD participants receiving vitamin D supplements after 24 weeks as a marker of adherence.
This record contains two datasets, an R script, Stata do file, and accompanying documentation:
The original study's ethical approvals state data will be used in ethically approved research only. Data will be shared once evidence of ethics approval is provided.
This record contains two datasets and accompanying scripts to analyse them:
The ‘EMD_minimal_deidentified’ dataset contains records on 97 participants who were randomly allocated to receive an electronic monitoring device and 72 participants who were randomly allocated to not receive one. It can be analysed with the Stata do file “Minimal dataset.do”. This do file replicates the pilot trial analysis of adherence and vitamin D level by EMD arm, among those who were receiving vitamin D supplement in the parent VITALITY trial.
The original study's ethical approvals state data will be used in ethically approved research only. Data will be shared once evidence of ethics approval is provided.
| Variable Name | Variable Label | Answer Label | Answer Code | Obs | Min | Max | Variable Type |
| arm | VITALITY treatment arm | 169 | 1 | 2 | Numeric | ||
| Intervention | 1 | ||||||
| Control | 2 | ||||||
| EMD | EMD arm | 169 | 0 | 1 | Numeric | ||
| No EMD | 0 | ||||||
| Used EMD | 1 | ||||||
| a04_sex | Participant sex | 169 | 1 | 2 | Numeric | ||
| Male | 1 | ||||||
| Female | 2 | ||||||
| age_exact | Participant age as decimal | Open ended | 169 | 11 | 20 | Numeric | |
| c01_enrol | Enrolled in school | 169 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| c02_schtype | Type of school | 143 | 1 | 3 | Numeric | ||
| Primary | 1 | ||||||
| Secondary | 2 | ||||||
| College/Vocational | 3 | ||||||
| vl10vload | Viral load | Open ended | 169 | 20 | 487652 | Numeric | |
| vlcat | viral load 3 categories | 169 | 0 | 2 | Numeric | ||
| <60 | 0 | ||||||
| 60-999 | 1 | ||||||
| >=1000 | 2 | ||||||
| sesquint | SES quintile | Open ended | 169 | 1 | 5 | Numeric | |
| pcgiver | Primary caregiver | 169 | 1 | 3 | Numeric | ||
| Mother or Father | 1 | ||||||
| Other | 3 | ||||||
| orphanhood | Orphanhood | 169 | 1 | 3 | Numeric | ||
| Both parents alive | 1 | ||||||
| 1 or both parents deceased | 2 | ||||||
| Unknown | 3 | ||||||
| base25OHD | 25OHD at baseline nmolL | Open ended | 169 | 29.7 | 120.8 | Numeric | |
| wk4825OHD | 25OHD at week 48 nmolL | Open ended | 167 | 39.2 | 142.2 | Numeric | |
| adhpc24 | Vitamin D adherence week 0-24 | Open ended | 420 | 0 | 100 | Numeric | |
| adhpc48 | Vitamin D adherence week 24-48 | Open ended | 397 | 0 | 100 | Numeric |
The ‘ml_preprocessed_for_R’ dataset contains records on 97 participants who received an electronic monitoring device. It can be analysed with the R script clustering_deidentified. This R script reproduces the unsupervised machine learning techniques for exploratory analysis of patterns of EMD use over 24 weeks, using k-means clustering, k-medoids clustering, hierarchical agglomerative clustering and Gaussian mixture model.
| Variable Name | Variable Label | Answer Label | Answer Code | Obs | Min | Max | Variable Type |
| arm | VITALITY treatment arm | 97 | 1 | 2 | Numeric | ||
| Intervention | 1 | ||||||
| Control | 2 | ||||||
| age | Age in years | Open ended | 97 | 11 | 20 | Numeric | |
| sesquint | SES quintile | Open ended | 97 | 1 | 5 | Numeric | |
| base25OHD | 25OHD at baseline nmolL | Open ended | 97 | 37.9 | 120.8 | Numeric | |
| wk4825OHD | 25OHD at week 48 nmolL | Open ended | 97 | 39.2 | 142.2 | Numeric | |
| vl10vload | Viral load | Open ended | 97 | 20 | 240149 | Numeric | |
| tot1 | EMD event wk 1 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot2 | EMD event wk 2 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot3 | EMD event wk 3 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot4 | EMD event wk 4 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot5 | EMD event wk 5 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot6 | EMD event wk 6 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot7 | EMD event wk 7 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot8 | EMD event wk 8 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot9 | EMD event wk 9 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot10 | EMD event wk 10 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot11 | EMD event wk 11 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot12 | EMD event wk 12 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot13 | EMD event wk 13 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot14 | EMD event wk 14 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot15 | EMD event wk 15 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot16 | EMD event wk 16 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot17 | EMD event wk 17 | 97 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot18 | EMD event wk 18 | 96 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot19 | EMD event wk 19 | 96 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot20 | EMD event wk 20 | 96 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot21 | EMD event wk 21 | 95 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot22 | EMD event wk 22 | 95 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot23 | EMD event wk 23 | 95 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| tot24 | EMD event wk 24 | 90 | 0 | 1 | Numeric | ||
| No | 0 | ||||||
| Yes | 1 | ||||||
| num_extra | Number of extra EMD events | Open ended | 97 | 0 | 10 | Numeric | |
| num_ooso | Number of out-of-schedule EMD events | Open ended | 97 | 0 | 75 | Numeric | |
| num_timepoints | Number of timepoints | Open ended | 97 | 17 | 24 | Numeric | |
| male | Participant sex assigned at birth | 97 | 0 | 1 | Numeric | ||
| Not male | 0 | ||||||
| Male | 1 | ||||||
| summer_enrol | Enrolment time | 97 | 0 | 1 | Numeric | ||
| Oct-Nov | 0 | ||||||
| July-Sep | 1 | ||||||
| orphan | Orphanhood | 93 | 0 | 1 | Numeric | ||
| Both parents alive | 0 | ||||||
| 1 or both parents deceased | 1 | ||||||
| non_parent_carer | Carer | 97 | 0 | 1 | Numeric | ||
| Mother or father | 0 | ||||||
| Other | 1 | ||||||
| high_art_burden | ART regimen at baseline | 97 | 0 | 1 | Numeric | ||
| fixed dose regimen | 0 | ||||||
| 2+ tabs regimen | 1 | ||||||
| min_age | Minimum age | Open ended | 97 | 11 | 11 | Numeric | |
| max_age | Maximum age | Open ended | 97 | 20 | 20 | Numeric | |
| s_age | Scaled age | Open ended | 97 | 0 | 1 | Numeric | |
| min_sesquint | Minimum sesquint | Open ended | 97 | 1 | 1 | Numeric | |
| max_sesquint | Maximum sesquint | Open ended | 97 | 5 | 5 | Numeric | |
| s_sesquint | Scaled sesquint | Open ended | 97 | 0 | 1 | Numeric | |
| min_base25OHD | Minimum base25OHD | Open ended | 97 | 37.9 | 37.9 | Numeric | |
| max_base25OHD | Maximum base25OHD | Open ended | 97 | 120.8 | 120.8 | Numeric | |
| s_base25OHD | Scaled base25OHD | Open ended | 97 | 0 | 1 | Numeric | |
| min_wk4825OHD | Minimum wk4825OHD | Open ended | 97 | 39.2 | 39.2 | Numeric | |
| max_wk4825OHD | Maximum wk4825OHD | Open ended | 97 | 142.2 | 142.2 | Numeric | |
| s_wk4825OHD | Scaled wk4825OHD | Open ended | 97 | 0 | 1 | Numeric | |
| min_vl10vload | Minimum vl10vload | Open ended | 97 | 20 | 20 | Numeric | |
| max_vl10vload | maximum vl10vload | Open ended | 97 | 240149 | 240149 | Numeric | |
| s_vl10vload | Scaled vl10vload | Open ended | 97 | 0 | 1 | Numeric | |
| min_num_extra | Minimum number extra | Open ended | 97 | 0 | 0 | Numeric | |
| max_num_extra | Maximum number extra | Open ended | 97 | 10 | 10 | Numeric | |
| s_num_extra | Scaled number extra | Open ended | 97 | 0 | 1 | Numeric | |
| min_num_ooso | Minimum number ooso | Open ended | 97 | 0 | 0 | Numeric | |
| max_num_ooso | Maximum number ooso | Open ended | 97 | 75 | 75 | Numeric | |
| s_num_ooso | Scaled number ooso | Open ended | 97 | 0 | 1 | Numeric | |
| min_num_timepoints | Minimum number timepoints | Open ended | 97 | 17 | 17 | Numeric | |
| max_num_timepoints | Maximum number timepoints | Open ended | 97 | 24 | 24 | Numeric | |
| s_num_timepoints | Scaled number timepoints | Open ended | 97 | 0 | 1 | Numeric |